A Congress worried about the scandal-weakened Food and Drug Administration Wednesday asked its new commissioner, Dr. David Kessler, to describe his prescription for healing the agency.
And Kessler, a former aide to Sen. Orrin Hatch, R-Utah, who was sworn in just last week, outlined a four-point therapy."First, we need to ensure the integrity of FDA and its programs; second, we need to strengthen enforcement and surveillance; third, we need to bolster management and infrastructure; and fourth, we need to manage the review of product applications," he said.
He blamed weaknesses in those areas for such things as the generic drug scandal and a backlog of drug applications for such diseases as AIDS.
Kessler outlined some details of his plans for the Senate Labor and Human Resources Committee, for which he was an adviser when Hatch was its chairman.
"It is imperative that we audit the data (from drug companies) on which FDA relies for product approvals. We have found fraud and misleading data, and it is possible that these practices are more widespread than we thought even two or three years ago," he said about his first priority.
"The FDA is on the move. We have vigorously begun our work on each of the four priorities I have identified. We are building the momentum that will sustain us," he said.
Hatch praised Kessler - who is both an attorney and a doctor - for his commitment and energy.